Registration Dossier

Administrative data

Description of key information

skin irritation (OECD 404): not irritating
eye irritation (OECD 405): not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

To cover the endpoint irritation of substance C12-15AE (CAS68131-39-5), studies from similar substances were taken for a weight-of-evidence approach.

Read-across is justified because of the structural similarity of the AE Members. The degree of ethoxylation has no impact on the irritation potential due to its narrow range (1-2.5) within the category. According to a voluntary industry programme to carry out Human and Environmental Risk Assessments on ingredients of household cleaning products (HERA) the irritation potential of AEs is decreasing with increasing ethoxylation degree. The lower ethoxylation level of EO 1 - 3, which includes all read-across substances, appeared to be more irritating (HERA, 2009).

Since the category chemicals differ mainly from each other only by the number of -CH2- units (except for the unsaturated group), the category is very homogenous and it is assumed that each category member exhibits the same toxic mode of action.

Based on weight of evidence and interpolation on the given study reports the following subcategories for skin irritation can be derived:

Class I:          short chain AEO (C6-11) ¿ not classified for skin irritation 

Class II:         detergent grade AEO (C12-15) ¿ not classified for skin irritation

Class III:        saturated long chain AEO (C16-18) ¿ not classified for skin irritation

Class IV:        unsaturated long chain AEO (C16/18 and C18 unsatd.) ¿ H315

The classification for skin irritation of the test material observed within the studies of Shell (1978) and Croda (1977) is based on a very rigorous treatment of the animals with the test material. Exposure to the test material under occlusive conditions is significantly higher than under the current OECD 404 prescribed exposure under semi-occluded conditions. Higher exposures will likely result in more severe effects. Hence, the results from this study over predict the irritation potential when assessed against new OECD 404 guidance criteria and classification of the test material is not justified. This is proven by weight of evidence approach within the AE category justification and within the study Shell (1993) where the criteria for classification are not met upon exposure to the test item under semi-occlusive conditions. Regarding skin irritation, the test substance does not meet the criteria for classification.

Regarding eye irritation, the test substance does not meet the criteria for classification according to Regulation (EC) No. 1272/2008. This result is in line with the outcome of a trend analysis performed for eye irritating properties of the members of the AE Category to evaluate the impact of carbon chain length distribution on the eye irritating properties. All available studies, performed according to OECD Guideline 405 under GLP conditions, applying AE of a high purity (> 95%) and an ethoxylation degree = 2.5 and allowing the evaluation of recovery (by day 21) were evaluated. According to this evaluation AE of the AE Category having a carbon chain length = C12 do not need to be classified for eye irritation/severe eye irritation. Based on this analysis C12-15AE (CAS 68131-39-5) is not classified for eye irritation. For further information please refer to the category justification.

Justification for selection of skin irritation / corrosion endpoint:
Reliable key study was chosen

Justification for selection of eye irritation endpoint:
Reliable OECD Guideline study

Justification for classification or non-classification

According to the classification criteria of Regulation (EC) No. 1272/2008 the substance does not need to be classified for eye or skin irritation.